Status:
COMPLETED
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
Lead Sponsor:
MedImmune LLC
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE3
Brief Summary
The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of...
Detailed Description
A randomized, double-blind, palivizumab-controlled, multi-center, multi-national trial conducted during 2 Northern Hemisphere RSV seasons with an intervening season in the Southern Hemisphere. Each ch...
Eligibility Criteria
Inclusion
- 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization
- OR:
- 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)
Exclusion
- Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)
- Mechanical ventilation or other mechanical support (including continuous positive airways pressure \[CPAP\])
- Life expectancy \< 6 months
- Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)
- Known renal impairment
- Known hepatic dysfunction
- Chronic seizure or evolving or unstable neurologic disorder
- Congenital heart disease \[CHD\] (children with uncomplicated CHD \[e.g., patent ductus arterious (PDA), small septal defect\] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)
- Known immunodeficiency
- Mother with HIV infection (unless the child has been proven to be not infected)
- Known allergy to Ig products
- Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
- Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
- Previous receipt of RSV vaccines
- Participation in other investigational drug product studies
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
6635 Patients enrolled
Trial Details
Trial ID
NCT00129766
Start Date
November 1 2004
End Date
May 1 2006
Last Update
August 28 2013
Active Locations (344)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35233
2
Alabama Neonatal Medicine OC
Pike Road, Alabama, United States, 35233
3
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
4
Central Arkansas Pediatric Clinic, PA
Benton, Arkansas, United States, 72015